Senior Validation Engineer

• Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements. 
• Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
• Must be able to review all FUSE System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
• Must be able to review, and update SOPs, forms, templates, documentation, and files.

• Significant working knowledge of engineering principles.
• Strong working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.
• Efficient Knowledge ISPE Baseline 5, Vol. 2 – Commissioning and Qualification and FDA industry regulations.
• Solid written and oral communication skills.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
• Ability to work with general guidance from Sr. Validation Engineers-Specialists /Validation Manager.
• Able to work in fast-paced, state of the art, alternately research and customized manufacturing facility. 

• Master’s Degree with two (2) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Bachelor’s Degree with four (4) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Associates Degree with six (6) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

• Degree in Engineering or Science Discipline.

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